Bio Pharma Dive
JULY 28, 2023
The British pharma is deepening its investment in genetic medicine through a deal for a group of Pfizer’s gene therapy delivery tools, while the New York giant cuts back.
Pharmaceutical Technology
JULY 24, 2023
Verrica has received approval from the US FDA for its YCANTH to treat molluscum in adult and paediatric patients aged two years and above.
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Rethinking Clinical Trials
JULY 27, 2023
Leaders of the NIH Pragmatic Trials Collaboratory hosted an onboarding meeting for the program’s 3 newest Demonstration Projects. The projects joined the program under the UG3 cooperative agreement mechanism to support a 1-year planning phase in preparation for potential transition to a UH3 implementation phase. Access the complete materials from the onboarding session.
BioSpace
JULY 26, 2023
Amid the impending drug pricing pressures from the Inflation Reduction Act, Roche is discontinuing a mid-stage hemophilia A gene therapy candidate and four early-stage hopefuls.
Bio Pharma Dive
JULY 27, 2023
GSK expects its respiratory syncytial virus vaccine will be a multibillion dollar product. But at the beginning it’s predicting a slower launch than for its fast-selling shingles shot.
Pharmaceutical Technology
JULY 25, 2023
Boehringer Ingelheim and Eli Lilly have secured approval from the EC for Jardiance to treat adults with chronic kidney disease (CKD).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Drug Patent Watch
JULY 28, 2023
Annual Drug Patent Expirations for SYMBICORT Symbicort is a drug marketed by Astrazeneca and is included in one NDA. It is available from three suppliers. There are eleven patents protecting… The post New patent expiration for Astrazeneca drug SYMBICORT appeared first on DrugPatentWatch - Make Better Decisions.
Bio Pharma Dive
JULY 24, 2023
Treatment with magrolimab proved ineffective in a Phase 3 study in myelodysplastic syndrome, adding to doubts about so-called CD47 inhibitors as well as Gilead’s deal strategy.
Pharmaceutical Technology
JULY 28, 2023
NS Pharma’s candidate would be the first to target Duchenne Muscular Dystrophy (DMD) patients amenable to exon 44 skipping therapy.
BioSpace
JULY 27, 2023
Despite beating analyst expectations, Takeda sustains a mid-stage defeat in a rare genetic disorder, leaving the fate of an investigational enzyme replacement therapy uncertain.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fierce Pharma
JULY 28, 2023
On Monday during a quarterly earnings call, when Biogen CEO Chris Viehbacher was asked about the company’s potential to execute M&A, he randomly offered “we’ve got, I think, about $7.3 billion | Biogen has revealed a proposal to acquire Reata Pharmaceuticals for $7.3 billion. The Texas-based rare disease specialist brings newly approved Skyclarys, the first treatment for the neurologic disorder Friedreich’s ataxia with peak sales potential of $1.5 billion.
Bio Pharma Dive
JULY 27, 2023
The results showed that enrollees who’d already lost weight after diet and exercise shed pounds after receiving Mounjaro, while those who stopped treatment gained weight back.
Pharmaceutical Technology
JULY 26, 2023
Eli Lilly has extended the tender offer expiration date for the acquisition of all Dice Therapeutics in a deal valued at $2.4bn.
ProRelix Research
JULY 26, 2023
Ensuring the safety and efficacy of new drugs, medical devices, and biological products does not end once the treatment is approved or is on the market but extends to the […] The post Pharmacovigilance (PV) Services at a Glance appeared first on ProRelix Research.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Fierce Pharma
JULY 28, 2023
Is AstraZeneca planning to peel off its China business? By CEO Pascal Soriot’s response to that question, it may only a contingency plan. | Is AstraZeneca planning to peel off its China business? By CEO Pascal Soriot’s response to that question, it may only be a contingency plan.
Bio Pharma Dive
JULY 27, 2023
The pharma said its latest shot, which covers 21 strains of bacteria, cleared two Phase 3 trials and in some cases spurred a stronger immune response than Pfizer’s Prevnar 20.
Pharmaceutical Technology
JULY 24, 2023
Shares in the company dropped by 29% despite assurances the failure would not harm its 2023 financial outlook.
Antidote
JULY 27, 2023
Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinical trials. Clinical trials evaluate new drugs, devices, packaging, and behaviors in order to determine if these potential therapies work for particular conditions or patient populations.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Fierce Pharma
JULY 27, 2023
To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” | To Roche’s pharma chief Teresa Graham, no word better describes the company’s eye drug Vabysmo right now than “momentum.” Approved by the FDA in January 2022, Vabysmo already crossed the one-billion-dollar sales mark in the first half of 2023.
Bio Pharma Dive
JULY 24, 2023
The Swiss pharma company is the latest large drugmaker to invest big in an experimental heart treatment, after years of prioritizing medicines for cancer and immune diseases.
Pharmaceutical Technology
JULY 27, 2023
GSK has reported an adjusted operating profit of £2.17bn in Q2 2023, which is an almost 8% increase from the £2.
Outsourcing Pharma
JULY 27, 2023
The EMA organized a task force made up of various stakeholders to gather insights on potential EU-level actions to improve the set up of clinical trials during public health emergencies.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Fierce Pharma
JULY 27, 2023
Eli Lilly continues to bolster the case for its dual GIP/GLP-1 agonist tirzepatide as a powerful weight loss agent. | Also known as Mounjaro in its approved type 2 diabetes indication, tirzepatide helped patients across two trials—Surmount-3 and Surmount-4—lose up to 26.6% of their body weight, Lilly said Thursday.
Bio Pharma Dive
JULY 28, 2023
The deal is a major bet by Biogen and its new CEO Chris Viehbacher, who’s reorganized R&D, cut costs and laid off staff since becoming company head last year.
Pharmaceutical Technology
JULY 27, 2023
Working in an industry with regular cross-border manufacturing and dealing with a global network of clients means adaptability is vital to maintaining good communications, building relationships, and managing teams effectively.
XTalks
JULY 27, 2023
Last week, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials. The agency also declined demands to overturn five earlier approvals regarding five distinct ortho-phthalates, alleged to significantly risk human health by leaching into food and beverage products.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
Fierce Pharma
JULY 27, 2023
Daiichi Sankyo's FLT3 inhibitor overcame FDA rejection to win an approval. Astellas signed another protein degrader deal, this time with PeptiDream. | Daiichi Sankyo's FLT3 inhibitor has overcome an FDA rejection to win an approval. Astellas signed another protein degrader deal. Takeda's enzyme replacement therapy flunked a mid-stage trial in a rare neurological disorder.
Bio Pharma Dive
JULY 24, 2023
The shot failed to meet a key goal of Bavarian Nordic’s Phase 3 study, a finding that separates it from marketed vaccines developed by Pfizer and GSK.
Pharmaceutical Technology
JULY 25, 2023
The global pharmaceutical industry experienced a 20% increased in company filings sentiment in Q2 2023 compared with the previous quarter, according to GlobalData’s analysis.
ACRP blog
JULY 26, 2023
As leaders in the clinical research enterprise seek to expand the public’s understanding of clinical trials and their potential benefits for healthcare at the personal, community, and national levels, communications tactics cannot remain stuck at the one-on-one rate of physician referrals or patient recruiters reaching out to individual potential volunteers for real progress to be seen.
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